1. Technical Field
The present invention relates to the field of medical items used during surgery. In particular, the invention pertains to an improved fenestrated surgical drape.
2. Description of the Related Art
Surgical drapes are used during surgery to create a sterile barrier around the surgical site. Surgical drapes having fenestrations, or openings, that are specifically designed for certain surgical procedures are well known. Typically, such drapes are structured with pre-shaped and pre-sized openings in contemplation of providing surgical access to a specific anatomical site of the patient. In this category of drape, the fenestration or opening is used for surgical access.
Another type of fenestrated drape is that which is configured to accommodate the anatomy through the fenestration but also to create the sterile field between the body portion containing the surgical site and the remainder of the patient's body via a conformable aperture. Thus, in this type of surgical drape, the fenestration provides surgical access and the aperture provides surgical isolation by sealing against the patient's body. One example of this type of fenestrated drape is one in which the aperture is elastomeric and generally dimensioned to accommodate a limb or other anatomical extension. Thus, when the limb is inserted through the opening, minor variations in natural geometry are accommodated by the flexibility of the elastomeric material. The elastomeric material further forms a tight seal circumscribing the anatomy, thereby forming a sterile barrier separating the surgical site from the remainder of the patient's body. Elastomeric aperture type fenestrated drapes afford the advantage of creating a secure air and fluid barrier between the sterile and non-sterile sites without requiring the use of supplemental tourniquets, taping and the like.
Current such fenestrated drapes are constructed by superimposing panels and portions of materials to seal the apertured panel to the base drape. The seal between the layers is conventionally formed using adhesives, such as double-sided adhesive areas to create a “square” seal around the perimeter of the aperture and the opening in the base drape.
One problem associated with current fenestrated surgical drapes is the risk of compromising the sterile field at the surgical site. In particular, although the elastomeric fit circumscribing the limb or other anatomical extension reduces the likelihood of contamination through the immediate area around the aperture, the perimeter of the apertured panel is still nevertheless dependent upon the adhesive between layers for the microbial barrier. Fluid, for example, can potentially transport across the adhesive seal between the layers surrounding the apertured panel.
Another problem with current fenestrated drapes, particularly with apertured panels incorporated into the drape, involves structural integrity. That is to say, current designs experience stress points during their use at certain locations around the perimeter of the attachment sites. On occasion, the stress results in separation of the seams at these sites, thereby compromising the sterile field surrounding the surgical site. Accordingly, the risk of exposure and infection at the surgical site is increased.
There is thus a need in the field of surgical drapes for a drape having an aperture with improved structural integrity and microbial barrier properties at the seal.